Biology in Patients With Reflux Esophagitis and Mucosal Impedance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change in local impedance of the esophageal mucosa
研究概览
简要总结
GERD is a common condition in the western world. In most cases, the diagnostic is established by good response to empiric proton pump inhibitor (PPI) therapy. When the patient symptoms are refractory to therapy, multiple invasive tests are available. The results of those tests (EGD, manometry, Ph monitoring and impedance) are clues that the physician use together to establish the diagnostic. No test however can be use alone because of their poor specificity and sensitivity. Recently, microscopy has been used to detect dilated intercellular space in between distal esophageal cells tissue; unfortunately this marker again failed to diagnose GERD.
In search of more sensitive and specific markers of GERD, we propose to assess if acid exposure affects: 1) gene and proteins expression in the esophageal/post-cricoid area tissue; and 2) local impedance of the mucosa. The secondary aim of this proposal is to determine if correlation exists between the two approaches.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Less than 18 years of age
- •Unable to provide informed consent
- •Use of acid suppressive therapy within last 14 days
- •known history of Barrett's esophagus, gastric surgery, alcoholism, significant motility condition
- •contraindications to biopsy such as taking anticoagulants other than aspirin (coumadin, plavix) or allergies to local anesthetic
结局指标
主要结局
Change in local impedance of the esophageal mucosa
时间窗: Chronic exposure
We are assessing if acid exposure affects local impedance of the mucosa
Change in gene and protein expression due to acid exposure in the esophagus
时间窗: Chronic exposure
We are assessing if acid exposure affects gene and protein expression in the esophageal/post-cricoid area tissue
次要结局
未报告次要终点
研究者
Michael Vaezi
Medical Director
Vanderbilt University Medical Center
